Tris(N-hydroxy-N-nitrosophenylaminato-O,O')aluminium

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

The test susbstance is negative in the Ames test.

Link to relevant study records

Reference

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

key study

Study period:

September-November 2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

yes (incl. QA statement)

Type of assay:

bacterial reverse mutation assay

Specific details on test material used for the study:

Name: Addtive 02-967 (GENORAD* 19)
CAS No.: 15305-07-4
Batch No.: SAN 149
Purity: > 98%
Chemical Name: Aluminium-N-nitrosophenylhydroxylamine (NPAL)
Aggregate State at RT: solid needles
Colour: whitish
Storage Conditions: room temperature, protected from light
Stability: Instable after repeated contact to air and/or light, undergoes hydrolysis
Expiry Date: 30 June 2003
Safety Precautions: The routine hygienic procedures were sufficient to assure personnel health and safety.

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2

Additional strain / cell type characteristics:

not applicable

Metabolic activation:

with and without

Metabolic activation system:

Rat liver S9 fraction (Aroclor 1254 induced)

Test concentrations with justification for top dose:

For S. typhimurium strains: 31.3, 62.5, 125.0, 250,0, 500.0 and 1000.0 µg/plate, based on the results of a range-finding toxicity test up to 5000 µg/plate in TA 100. These concentrations were also used in the first and in the second mutagenicity test.
In a supplement test to the first mutagenicity tes with E. coli WP2 uvrA: 500, 1000 and 2000 µg/plate. In the second test with E. coli WP2 uvrA, the following concentrations were used: 62.5, 125.0, 250,0, 500.0,1000.0 and 2000.0 µg/plate.

Vehicle / solvent:

dimethyl sulphoxide (DMSO)

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

4-nitroquinoline-N-oxide

Remarks:

E. coli WP2 uvrA, without metabolic activation

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

sodium azide

Remarks:

TA 1535 and TA 100, without metabolic activation

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

9-aminoacridine

Remarks:

TA 1537, without metabolic activation

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

2-nitrofluorene

Remarks:

TA 98, without metabolic activation

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

cyclophosphamide

Remarks:

TA 1535, with metabolic activation

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 2-aminoanthracene

Remarks:

E. coli, TA 100, TA 98, TA 1537, with metabolic activation

Key result

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Key result

Species / strain:

S. typhimurium TA 1537

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Key result

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Key result

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Key result

Species / strain:

E. coli WP2 uvr A

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Conclusions:

The test substance is considered to be non-mutagenic in the S. typhimurium and E. coli reverse mutation assay.

Executive summary:

Under the experimental conditions reported, the test substance did not induce gen mutations by base-pair changes or frameshifts in the genome of any of the strains used. Therefore, the test substance is considered to be non-mutagenic in the S. typhimurium and E. coli reverse mutation assay.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)

Genetic toxicity in vivo

Endpoint conclusion

Endpoint conclusion:

no study available